MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS / ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Model Number FREESTYLE LIBRE 2

Device Problems Defective Device (2588); Compatibility Problem (2960)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 07/08/2023

Event Type  Injury  

Event Description

New abbott diagnostics freestyle libre 2 sensors and reader failed multiple times with unit displayed error "incompatible sensor this sensor cannot be used with this reader".Abbott support instructed me to inject all sensors into body to prove it / they were defective or they would not render further support.Also instructed me to contact issuing pharmacy for help.My arm is sore and red from multiple injections.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIAGNOSTICS / ABBOTT DIABETES CARE INC.
• MDR Report Key: 17336965
• MDR Text Key: 319351455
• Report Number: MW5119515
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: FREESTYLE LIBRE 2
• Device Lot Number: KTP006466
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: INSULIN, BOTH SHORT AND LONG ACTING.; TIRZEPATIDE.
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White